METHOD FOR SYMPATHETIC REBALANCING OF PATIENT

• US 20120172680A1
• Filed: 12/28/2011
• Published: 07/05/2012
• Est. Priority Date: 12/28/2010
• Status: Abandoned Application

• Current Assignee: Cibiem, Inc.
• Original Assignee: G & L Consulting LLC.
• Inventors: Gelfand, Mark, Levin, Howard
• Application Number:
  US13/338,876
• Publication Number:
  US 20120172680A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

A method and device for assessing, and treating patients having sympathetically mediated disease, such as cardiac, metabolic, or pulmonary disease involving chemoreceptor hyperactivity and heightened sympathetic tone by reducing chemosensor input to the nervous system.

Claims

1. A method to screen for treatment a patient suffering a sympathetically mediated disease, the method comprising:

determining whether the patient has a high sympathetic tone;

assessing the activity of the carotid body in the patient, and

based on the assessment of the activity of the carotid body and the determination that the patient has a high sympathetic tone, determining whether the patient is a candidate for the treatment.

2. The method of claim 1 wherein the high sympathetic tone is above a sympathetic tone considered normal for the patient.

3. The method of claim 1 wherein the high sympathetic tone is a sympathetic tone level a certain degree above a sympathetic tone level considered normal for the patient.

4. The method of claim 1 wherein the sympathetically mediated disease is at least one of a group of diseases consisting of:

hypertension, drug resistant hypertension, hypertension resistant to renal denervation, diabetes, periodic breathing, insulin resistance and heart failure.

5. The method of claim 1 wherein the determination of the sympathetic tone includes detecting in the patient at least one of:

a high heart rate, a high muscle sympathetic nerve activity, a high level of catocolomines in blood or urine.

6. The method of claim 1 wherein the assessment of the activity of the carotid body includes imaging a region of the patient corresponding to the carotid body and determining a hypertrophy of the carotid body.

7. The method of claim 1 wherein the assessment of the activity of the carotid body includes determining if hyperventilation and hypocarbia are present at rest.

8. The method of claim 1 wherein the assessment of the activity of the carotid body comprises assessing chemosensitivity.

9. The method of claim 1 wherein the assessment of the activity of the carotid body includes stimulating a tissue of the patient and monitoring the physiological response of the patient to the simulation.

10. The method of claim 9 wherein the monitored physiological response is selected from a group consisting of:

respiration, heart rate, blood pressure, blood flow, and muscle sympathetic nerve activity.

11. The method of claim 9 wherein the stimulation of the tissue includes at least one of an electrical stimulation, mechanical stimulation, and a chemical stimulation.

12. The method of claim 9 wherein the stimulation of the tissue includes an electrical stimulation having at least one of:

an amperage of one to ten milliamps, a frequency of ten to fifty Hertz, and a pulse duration of fifty to five hundred microseconds.

13. A method to assess a patient for a treatment to suppress activity of the carotid body in the patient, the method comprising:

selecting the patient based on a diagnosis that the patient suffers from a sympathetically mediated disease;

determining that the patient has a high sympathetic tone;

assessing the activity of the carotid body in the patient;

based on the assessment of the activity of the carotid body and the determination that the patient has a high sympathetic tone, determining that the patient is a candidate for the treatment;

after the treatment determining whether the activity of the carotid body is below the assessed activity of the carotid body prior to the treatment, and

determining if the lowering of the carotid body activity achieved a therapeutic effect with respect to the sympathetically mediated disease.

14. The method of claim 13 wherein the high sympathetic tone is higher than a sympathetic tone considered normal for the patient.

15. The method of claim 13 wherein the high sympathetic tone is a sympathetic tone level a certain level above a sympathetic tone level considered normal for the patient.

16. The method of claim 13 wherein the sympathetically mediated disease is at least one of a group of diseases consisting of:

hypertension, drug resistant hypertension, hypertension resistant to renal denervation, diabetes, periodic breathing, insulin resistance and heart failure.

17. The method of treatment of claim 13 wherein the determination of the sympathetic tone includes detecting in the patient at least one of:

a high heart rate, a high muscle sympathetic nerve activity, a high level of catocolomines in blood or urine.

18. The method of claim 13 wherein the assessment of the activity of the carotid body includes stimulating a tissue of the patient and monitoring the response of the patient to the stimulation.

19. The method of claim 18 wherein the step of determining whether the activity of the carotid body is below the assessed activity includes repeating the stimulation of the tissue after the treatment and comparing the responses to the stimulation before the treatment to the response to the stimulation after the treatment.

20. A method of treatment comprising:

assessing the activity of a carotid body in a patient;

determining to suppress the activity of the carotid body of the patient based on the assessed activity, and

suppressing the carotid body by accessing a region proximate to the carotid body in the patient.

21. The method of claim 20 further comprising determining whether the suppression of the activity of the carotid body achieved a therapeutic effect in the patient.

22. The method of claim 20 wherein the therapeutic effect is a reduction in the suffering of the patient due to a sympathetically mediated disease.

23. The method of treatment of claim 22 wherein the sympathetically mediated disease includes a least one of hypertension, diabetes, insulin resistance and heart failure.

24. The method of treatment of claim 20 wherein the sympathetically mediated disease is at least one from a group of diseases consisting of:

hypertension, drug resistant hypertension, hypertension resistant to renal denervation, diabetes, periodic breathing, insulin resistance and heart failure.

25. The method of treatment of claim 20 further comprising determining that the patient has a sympathetic tone higher than a threshold level.

26. The method of claim 25 wherein the threshold sympathetic tone is greater than a sympathetic tone considered normal for the patient.

27. The method of claim 25 wherein the threshold sympathetic tone is a sympathetic tone level a certain degree above a sympathetic tone level considered normal for the patient.

28. The method of treatment of claim 20 further comprising determining whether the patient has a high central sympathetic tone.

29. The method of treatment of claim 28 wherein the determination of the high central sympathetic tone includes detecting in the patient at least one of:

a high heart rate, a high muscle sympathetic nerve activity, a high level of catocolomines in blood or urine.

30. The method of treatment of claim 20 wherein assessing the activity of the carotid body of the patient comprises detecting a combination of hyperventilation and hypocapnia in the patient at rest.

31. The method of treatment of claim 20 suppressing the carotid body comprises ablating the carotid body.

32. The method of claim 31 wherein the ablation of the carotid body includes performing an endovascular procedure comprising:

connecting a proximal region of a catheter to an energy source;

positioning a distal region of the catheter into a carotid artery of the patient;

applying energy from the energy source to the proximal region of the catheter which conveys the energy to the distal region;

delivering energy from the distal region of the catheter to an area of carotid artery bifurcation in the carotid artery, wherein the delivery of energy ablates at least a portion of the carotid body or carotid body nerves, and

withdrawing the catheter from the carotid artery and from the patient after the ablation.

33. The method of claim 32 wherein the positioning of the distal region of the catheter in the carotid artery includes:

applying a low level of energy from the energy source to the proximal region of the catheter and conveying the energy to the distal region;

delivering the low level of energy from the distal region to the carotid artery;

detecting a response to the low level of energy by a nerve proximate to the carotid artery, and

repositioning the distal region in the carotid artery, if the detected response is from a nerve other than the carotid body.

34. The method of claim 33 wherein the low level of energy is a non-ablating, nerve-excitatory level of energy.

35. The method of claim 20 further comprising determining that the distal region is in position for suppressing the carotid body if the detected response is from the carotid body.

36. The method of claim 33 wherein the low level of energy is electrical current delivered by the distal region of the catheter to the carotid artery.

37. The method of claim 33 wherein the steps of delivering the low level of energy, detecting the response and repositioning the distal region are repeated until the detection of the response from the carotid body.

38. The method of claim 33 wherein the steps of delivering the low level of energy, detecting the response and repositioning the distal region are repeated until the detection of sympathetic trunk, vagal, or hypoglossal nerve stimulation is below a threshold level.

39. The method of claim 33 wherein the ablation of the carotid body is performed with a percutaneous procedure.

40. The method of claim 20 wherein suppressing the carotid body comprises positioning a catheter having a distal region proximate to the carotid body, wherein the positioning is assisted by imaging the catheter in the patient with at least one technique of the group consisting of:

magnetic resonance imaging (MRI), sonography, computed tomography (CT) and fluoroscopy.

41. The method of claim 32 wherein the positioning of the catheter includes:

stimulating a tissue of the patient to provoke a sympathetic physiological response by the patient;

monitoring the physiological response to the stimulation, and

based on the response, determining whether the distal region is properly positioned in the carotid artery.

42. The method of claim 41 wherein properly positioned includes determining that at least one of the sympathetic trunk, hypoglossal nerve, or vagus nerve are not sufficiently proximate to the distal region to be injured by the ablation.

43. The method of claim 41 wherein the physiological response includes at least one of a muscle twitch, a tongue movement, a reduction of heart rate and a reduction of blood pressure.

44. The method of claim 32 wherein the step of positioning the catheter includes stimulating the tissue after the ablation, monitoring the response to the stimulation, and if an increase in sympathetic physiological response is detected determining that the carotid body was not sufficiently ablated, and

the method further comprises repeating the ablation step.

45. The method of claim 32 wherein the step of positioning the catheter includes stimulating the tissue after the ablation, monitoring the response to the stimulation, and if an absence of a sympathetic physiological response is detected determining that the carotid body was sufficiently ablated.

46. The method of claim 32 wherein the step of stimulating a tissue is performed at a plurality of tissue sites and the monitoring of the physiological response is performed for each the tissue sites.

47. The method of claim 41 wherein the step of ablation is performed at one of the tissue sites for which the corresponding physiological response includes a sufficient sympathetic physiological response and a below threshold level of a parasympathetic physiological response.

48. A method to adjust autonomic balance in a patient having high sympathetic activity relating to parasympathetic activity comprising:

artificially reducing a peripheral chemosensor output to the central nervous system of the patient.

49. The method of claim 48 wherein the sympathetic prevalence is due to an elevated sympathetic tone.

50. The method of claim 48 wherein the reduction of the peripheral chemosensor output comprises ablating at least one of:

the carotid body and the nerves innervating the carotid body.

51. The method of claim 48 wherein the reduction of the peripheral chemosensor output includes at least one of reducing hyperventilation and hypocapnia.

52. The method of claim 48 further comprising selecting the patient based on whether the patient has a hyperventilation or hypocapnea condition.

53. A method to reduce hyperventilation or hypocapnia in a patient having congestive heart failure or hypertension comprising artificially reducing a peripheral chemosensor output to a central nervous system of the patient.

54. The method of claim 53 further comprising protecting the brain from an embolism while reducing the peripheral chemosensor output to the central nervous system.

55. The method of claim 53 wherein protecting the brain includes positioning an endovascular balloon in the internal carotid artery of the patient.

56. The method of claim 55 wherein protecting the brain includes positioning an endovascular filter in the internal carotid artery of the patient.

57. The method of claim 53 further comprising thermally protecting at least one of the carotid sinus, sympathetic trunk, internal jugular vein, hypoglossal or vagus nerves.

58. The method of claim 53 further comprising repeatedly assessing the peripheral chemosensor output.

59. A method to treat a patient having sympathetically mediated disease comprising:

diagnosing a patient as suffering from a sympathetically mediated disease;

screening the diagnosed patient based on whether the patient has a chemosensitivity exceeding a threshold level of chemosensitivity;

if the chemosensitivity exceeds the threshold level, selecting the patient for suppression of activity of a carotid body in the diagnosed patient and excluding the patient from selection if the chemosensitivity is below the threshold level, and

suppressing the activity of the carotid body of the selected patient.

60. The method of claim 59 further comprising determining whether the suppression of the carotid body achieved a therapeutic effect by reducing the suffering of the patient due to the sympathetically mediated disease.

61. The method of claim 59 wherein the screening is based on the peripheral chemosensitivity of the patient.

62. The method of claim 59 wherein the screening based on the chemosensitivity is determined based on respiratory response of the patient to breathing a gas mixture having at least one of:

an oxygen (O₂) content below a normal content for atmospheric air, and a carbon dioxide (CO₂) content higher than a normal content for the atmospheric air.

63. A method to treat cardiac, metabolic, and pulmonary diseases including:

positioning an ablation device in a vascular system of a mammalian patient, wherein an ablating region of the ablation device is in a carotid artery of the vascular system and proximate to a carotid body of the mammalian patient;

forming a lesion on tissue at or proximate to the carotid body by ablating the tissue using the ablation device;

suppressing a chemoreflex function of the carotid body due to the lesion, and

removing the ablation device from the patient.

64. The method as in claim 63 wherein the ablation device includes a catheter and the ablating region is at a distal tip of the catheter, wherein the positioning step includes positioning the distal tip proximate to a carotid artery of the patient, wherein the energy is applied through the distal tip to ablate the tissue.

65. The method of claim 63 further comprising determining that the mammalian patient suffers from a cardiac, metabolic, or pulmonary disease, and treating the disease by the suppression or inhibiting the natural carotid body chemoreflex functions.

66. The method of claim 65 wherein the ablation is performed by applying heat energy to the tissue.

67. The method of claim 65 wherein the ablation is performed by applying electrical energy at a radio frequency (RF) and the RF energy is applied to ablate the tissue.

68. The method of claim 65 wherein the application of energy and the ablation steps are performed during a period of less than one minute.

69. The method of claim 65 wherein the ablation does not significantly ablate tissue distal to the carotid body.

70. The method of claim 65 wherein the ablation does not ablate baroreceptors.

71. A method comprising:

applying energy to mammalian tissue at or proximate to a carotid body of a mammalian patient, wherein the energy is applied by a distal region of a catheter inserted in a vascular system of the patient and the energy is supplied from an energy source external to the patient;

ablating the tissue at or proximate to the carotid body due to the application of the energy;

forming a lesion at the tissue due to the ablation of the tissue;

removing the catheter from the patient, and

suppressing or inhibiting natural carotid body chemoreflex functions due to the lesion and after removal of the catheter.

72. The method of claim 71 further comprising inserting a distal tip of a catheter into a carotid artery of the patient, wherein the energy is applied through the distal tip to cause the ablation of the tissue.

73. The method of claim 71 further comprising determining that the mammalian patient suffers from a cardiac, metabolic or pulmonary disease, and treating the disease by the suppression or inhibiting the natural carotid body chemoreflex functions.

74. The method of claim 71 wherein the energy is an electrical energy at radio frequency (RF) and the RF energy is applied to ablate the tissue.

75. The method of claim 71 wherein the application of energy and the ablation steps are performed during a period of less than one minute.

76. The method of claim 71 wherein the ablation does not significantly ablate tissue distal to the carotid body.

77. The method of claim 71 wherein the ablation does not ablate baroreceptors.

78. A method to inhibit chemoreflex function generated by a carotid body in a mammalian patient to treat at least one of heart failure and hypertension, the method comprising:

positioning an ablation device in a vascular system of the patient such that a distal section of the ablation device is proximate to or at the carotid body of the patient;

supplying energy to a distal section of the ablation device wherein the energy is supplied by an energy supply apparatus outside of the patient;

applying the energy from the energy supply through the ablation device to the distal section to ablate tissue proximate to or included in the carotid body;

forming a lesion at the tissue due to the ablation of the tissue;

removing the ablation device from the patient, and

inhibiting carotid body chemoreflex functions due to the lesion and subsequent to the removal of the distal section.

79. The method of claim 78 wherein the energy is an electrical current and is applied to an electrode at the distal section of the ablation device.

80. A method for reducing abnormally elevated chemoreflex signals to treat at least one of acute heart failure, and hypertension, the method comprising:

positioning an ablation device in a vascular system of the patient such that a distal section of the ablation device can apply energy to tissue of the patient proximate to or included in the carotid body of the patient;

supplying energy to a proximal section of the ablation device wherein the energy is supplied by an energy supply apparatus outside of the patient;

applying the energy from the energy supply through the ablation device to the distal section to ablate the tissue;

forming a lesion at the tissue due to the ablation of the tissue;

removing the ablation device from the patient, and

inhibiting carotid body chemoreflex functions due to the lesion and subsequent to the removal of the distal section.

81. The method of claim 80 further comprising determining that the mammalian patient has abnormally elevated chemoreflex.

82. The method of claim 80 wherein the energy applied to ablate the tissue is at least one of a microwave electric energy, an electrical field, a cryogenic energy and laser energy.

83. The method of claim 80 wherein the ablation substantially preserves natural carotid sinus baroreflex.

84. A method to treat a sympathetically mediated disease comprising:

identifying a patient having enhanced sensitivity of chemoreceptors;

directly reducing, inhibiting or removing output from at least one peripheral chemoreceptor using a surgical technique or a minimally invasive interventional technique, and

the direct reduction, inhibiting or removal achieves an autonomic balance via modulation of peripheral chemoreflex.

85. The method of claim 84 wherein the surgical technique or the minimally invasive interventional technique is selected from a group consisting of:

endovascular catheterization or percutaneous puncture guided and assisted by MRI, sonography, CT or fluoroscopy.

86. The method of claim 84 wherein the surgical technique or the minimally invasive interventional technique includes ablation of glomus cells, related afferent nerve endings, or related adjacent structures in a carotid body or an aortic body of the patient.

87. The method of claim 84 further comprising monitoring the patient after the surgical technique or the minimally invasive interventional technique to determine whether the patient suffers less from at least one of the conditions in the group of conditions consisting of:

sensation of breathlessness, vasodilation, sympathetic activation, fluid retention, glucose metabolism and hypertension.

88. The method of claim 87 wherein the determination of whether the patient suffers is made by comparing the one of the conditions of the patient prior to the surgical technique or the minimally invasive interventional technique to the one of the conditions after the surgical technique or minimally invasive interventional technique.

89. The method of claim 87 wherein the surgical technique or the minimally invasive interventional technique includes surgical modulation of a peripheral chemoreceptor of the patient.

90. The method of claim 84 wherein the surgical technique or the minimally invasive interventional technique includes at least one of a group consisting of:

direct, laparoscopic or endoscopic access to a peripheral chemoreceptor through an incision in the skin of the patient.

91. The method of claim 84 further comprising stimulation of the patient to confirm identification of a chemoreceptor prior to performance of the surgical technique or the minimally invasive interventional technique.

92. The method of claim 84 further comprising stimulation of the patent after the surgical technique or the minimally invasive interventional technique to confirm reduction in chemoreceptor sensitivity.